Catheter placement unit

ABSTRACT

THE COMBINATION OF THE CATHETER PLACEMENT INCLUDING A NEEDLE AND A CATHETER TELESCOPICALLY ASSOCIATED THEREWITH AND WHEREIN THE NEEDLE IS RETRACTABLE RELATIVELY TO THE CATHETER FOLLOWING PUNCTURE OF A BODY LUMEN, AND LOCKING MEANS TO HOLD THE NEEDLE IN RETRACTED POSITION IN SUCH MANNER THAT THE PATIENT&#39;&#39;S BODY IS EFFECTIVELY PROTECTED FROM CONTACT OF THE NEEDLE POINT.

Oct. 30, 1973 J. 1.. SORENSON ETAL Re. 27,797

CATHETER PLACEMENT UNIT Original Filed June 8, 1966 2 Sheets-Sheet 1 BY/W w av w 08h 1973 J. L. SORENSON r-rrAL Re. 27,797

CATHETER FLAG EMENT UN IT Original Filed June 8, 1966 2 Sheets-Sheet 2 227 IZZ 1 N VENTOR.

/4 M65 1 5aeg/vso/v 5 g M w WO HTTORNEYS United States Patent Oflice Re.27,797 Reissuecl Oct. 30, 1973 27,797 CATHETER PLACEMENT UNIT James L.Sorenson, Salt Lake City, Utah, and Wallace H.

Ring, P.0. Box 1133, Salt Lake City, Utah; said Sorenson assignor tosaid Wallace H. Ring Original No. 3,463,152, dated Aug. 26, 1969, Ser.No. 556,194, June 8, 1966. Application for reissue Dec. 14, 1970, Ser.No. 97,627

Int. Cl. A61m /00 US. Cl. 128-2144 13 Claims Matter enclosed in heavybrackets appears in the original patent but forms no part of thisreissue specification; matter printed in italics indicates the additionsmade by reissue.

ABSTRACT OF THE DISCLOSURE The combination of the catheter placementunit including a needle and a catheter telescopically associatedtherewith, and wherein the needle is retractable relatively to thecatheter following puncture of a body lumen, and locking means to holdthe needle in retracted position in such manner that the patients bodyis effectively protected from contact of the needle point.

This invention or discovery relates to improvements in a catheterplacement unit, and more particularly to a unit highly desirable forplacing a small catheter in a surface vein where large quantities ofinfusion fluid are not necessarily needed in a minimum of time, althoughthe placement unit will have other uses and purposes as will be apparentto one skilled in the art.

Catheter placement units heretofore made and suitable for thecannulation of surface veins frequently resulted in infiltration ofinfusion liquid into tissues adjacent to a vein, and such infiltrationwould likely occur in half the cases where a 24 hour infusion wasindicated. Also, with formerly known catheter placement units,difficulty was frequently experienced in making a proper venipuncture;the bulk of the apparatus was mentally depressing to the patient; andthe needle could not be retracted and locked in position relatively tothe catheter.

With the foregoing in mind, it is an important object of the instantinvention to provide a catheter placement unit wherein the catheter isconnected to the source of infusion in a leakproof manner, wherebyinfusion liquid does not directly contact the inside of a hollow needle,and infiltration of infusion liquid into adjacent tissues is eliminated.

Another important object of this invention is the provision of acatheter placement unit highly desirable for use in connection withsurface veins, and wherein the needle with which the venipuncture ismade is retractable relatively to the catheter and locked in itsretracted position with the point of the needle well protected.

Also an object of this invention is the provision of a catheterplacement unit which is so constructed that the needle may be disposedalmost parallel to a surface vein at the time of venipuncture, and thedevice being of a relatively small size without bulkiness that mightcreate a psychological fear or distress in the patients mind.

While some of the more salient features, characteristics and advantagesof the instant invention have been above pointed out, others will becomeapparent from the following disclosures, taken in conjunction with theaccompanying drawings, in which:

FIGURE 1 is a fragmentary part sectional part elevational viewillustrating a catheter placement unit embodying principles of thisinvention in use;

FIGURE 2 is a fragmentary plan view of the structure of FIGURE 1 afterthe catheter has been placed and the needle locked in a harmlessposition;

FIGURE 3 is an enlarged fragmentary vertical sectional view, takensubstantially as indicated by the line lIIIII of FIGURE 2, looking inthe direction of the arrows;

FIGURE 4 is a greatly enlarged fragmentary transverse vertical sectionalview taken substantially as indicated by the line IV-IV of FIGURE 2;

FIGURE 5 is a fragmentary side elevational view of another form ofcatheter placement unit embodying principles of this invention;

FIGURE 6 is a fragmentary enlarged vertical sectional view takensubstantially as indicated by the line VIVI of FIGURE 5;

FIGURE 7 is a side elevational view of another form of catheterplacement unit embodying principles of this invention;

FIGURE 8 is a top plan view of the structure of FIG- URE 7; and

FIGURE 9 is a vertical sectional view of the structure of FIGURES 7 and8 taken substantially as indicated by the line IX-IX of FIGURE 8,showing the structure after the catheter has been placed.

All the illustrated embodiments of the instant invention have been shownexaggerated in size for purposes of clarity. Although the catheterplacement units may be made in various sizes, for use with children oradults, and the catheters may be of various lengths depending upon whatparticular lumen of the body they are to be placed within, when utilizedfor cannulating surface veins, the placement units will he considerablysmaller than illustrated.

With reference now to FIGURES l to 4 inclusive, it will be seen that thefirst illustrated embodiment of the instant invention includes a holdingmember 1 shaped to provide opposed side wings 2 and 3. This member maybe formed of a suitable plastic material and is flexible althoughpossessing far more rigidity than the catheter to be placed. Centrallythereof the member 1 is provided with a pair of spaced upstanding ribs 4and 5 paralleling the longitudinal axis of the entire placement unit anddefining a groove therebet'ween.

The placement unit also includes a hollow needle 6 having a pointed end7 thereon to effect body puncture, and at the opposite end the needle isprovided with a hub 8 with an upstanding flange 9 thereon. The hub 8 ofthe needle is slidable inside a plastic sheath 10 having a longitudinalslit 11 therein, the aforesaid flange 9 being of suflicient height toextend through the slit. The sheath may satisfactorily be extrudedplastic, such as polyethylene, and is of suflicient resiliency that theslit normally remains closed. The slit terminates short of the outer endof the sheath, leaving a solid portion 12 of the sheath at the outerterminal end thereof. The other end of the sheath is secured to theholding member 1 adjacent the ribs 4 and 5 as seen at 13.

Secured within the closed end 12 of the sheath II] is one end portion ofa tube 14 which may be of plastic highly flexible material and which isof indefinite length, leading directly to a coupling with an infusionline depending from a bottle or other source of infusion liquid. Thistube may be fused or adhesively connected to the sheath 10 as may bedeemed most expedient. A catheter 15 extends through the sheath 10 andis disposed within the lumen of the needle 6, with one end terminatingjust inside the point of the needle and the other end fused oradhesively secured to the inside of the aforesaid infusion tube 14. Thecatheter is thus maintained sterile within the sheath 10 and the needle6 until it is placed in the body of a patient.

At the outset, the placement unit is assembled with the needle hubdisposed between the ribs 4 and 5 on the 3 holding member 1, as seen inFIGURE 1. Of course there is the usual tubular protective cap disposedover the needle, which is not shown, and the entire unit is packaged ina sterile wrapper.

In use, the unit is extremely simple and effective. The sterile wrapperis opened, and the tube 14 connected to an infusion system. The needlecap is removed, and by grasping the flange 9 on the needle hub theneedle is retracted just sufficiently to expose the end of the catheter.Infusion is then turned on and the catheter flushed out with infusionliquid to remove air and sterilization sediment, if any, from thecatheter. The infusion is then turned off, and the needle advanced sothe needle point is just beyond the end of the catheter. The flanges 2and 3 of the holding member 1 are then bent upwardly and gripped betweenthe thumb and finger of the attending surgeon as indicated at 16 inFIGURE 1. The upward bending of the flanges 2 and 3 causes the ribs 4and 5 to tightly grip the needle hub so that there is no danger ofslippage during venipuncture. The point of the needle is then insertedinto the body 17 of a patient and then advanced to the desired extentinto a vein 18, such as a vein on the back of the hand for example.Blood flowing backward through the needle and possibly into the catheteras well will be visible through the transparent sheath to denote that aproper venipuncture has been made. After the needle has been advancedinto the vein, the wings 2 and 3 are held flatly against the patientlsbody, and the needle is retracted by grasping the upstanding flange 9and moved to the position seen in FIGURES 2 and 3 with the point 7 ofthe needle lying between the ribs 4 and 5, the catheter remainingextended in the lumen of the patient. The needle cannot be retracted toofar because when the flange 9 contacts the closed end of the sheath atthe end of the slit 11, the point of the needle will be properlydisposed. A strip 19 of adhesive tape is then attached to the patientsbody across the sheath 10 immediately adjacent the upstanding flange 9on the needle hub as seen clearly in FIGURES 2 and 3, to lock the needlein its retracted position and prevent any forward movement of the needlethereafter which might result in injury to the catheter. A strip 20 ofadhesive tape is also laid over the holding member 1, directly over theribs 4 and 5 and the needle point to hold the entire unit securely onthe patients body with the catheter properly entered into the vein.

Two pieces of adhesive tape may be packaged along with the catheter unitso as to be immediately available and ready for use.

It will be noted that with the instant placement unit, the catheter isat all times sealed off from the needle in a leakproof manner, so thatthere cannot be any infiltration of infusion liquid into the body tissueadjacent the vein. There is no danger to the patient from the point ofthe retracted needle, nor any danger of injury to the catheter by virtueof unexpected forward movement of the needle, because the needle issecurely locked in the retracted position and the point thereof wellcovered. Also, the device lies flatly on the patient's body, without anyobjectionable bulk that might cause a psychological reaction in thepatients mind.

In that embodiment of the invention seen in FIG- URES 5 and 6, theneedle is retracted after venipuncture by pulling on the end of alanyard. With this form of the invention, it is impossible to advancethe catheter beyond the point of the needle, and yet the venipuncturemay be tested [teted] after the needle and catheter have been placedwithin a vein to the desired extent.

This form of the invention embodies a tubular sheath 21 of transparentplastic material, and which is imperforate except for a single smallaperture 22. One end of this sheath is securely anchored to a flangedhub 23, one portion of the flange being flattened as indicated at 24 sothat the structure will lie more closely against the 4 body of apatient. A hollow needle 25 extends through the hub 23 and inside of thesheath 21 the [outer] inner end of the needle is circumscribed by a hubelement 26 which securely locks one end of a lanyard 27 to the needle,this lanyard projecting out the aforesaid aperture 22 at the other endof the sheath.

The other [outer] end of the sheath 21 is secured to one end of a shorttube 28, and the other end of the tube 28 is secured to a tube 29leading from an infusion system. A catheter 30 is disposed within thesheath 21, having its outer end secured within the tube 28, and theother end of the catheter terminates within the needle 25 just insidethe point of the needle.

It should be noted that, to be operative, this embodiment must also beprovided with means for holding the needle during venipuncture. This maybe accomplished either as in the first embodiment, by use of grippingflanges (holding member I) attached to the forward end of the sheath, orby making the sheath flexible so hub 26 can be gripped or pushed duringvenipuncture without contaminating the needle.

With this structure, it is a simple expedient to connect the tube 29 toan infusion system, flush out the catheter with infusion liquid if sodesired, then turn off infusion, and grasp the unit at or adjacent tothe hub 26 [23] and make a proper venipuncture to the desired extent.When venipuncture is established, merely by pulling upon the lanyard theneedle may be retracted relatively to the catheter until the point ofthe needle is inside the hub 23, and infusion again started. The devicemay be taped to the body of the patient as above described in connectionwith the first embodiment of the invention, and the lanyard may beknotted or a piece of adhesive tape secured thereto to prevent anyunintentional movement of the needle relatively to the catheter.

In that embodiment of the invention seen in FIGURES 7, 8 and 9, aplastic tube 31 is utilized, and this tube is provided withdiametrically opposed and relatively large slots 3232 therein so as todefine a pair of opposed inwardly arcuate tracks 33--33. One end of thistube 31 is provided with a nipple 34 to receive the usual needleprotective cap, not shown. The other end of the tube is provided with anipple 35 for connection with an infusion system. A hollow needle 36having a pointed end 37 projects through the nipple 34 when theplacement unit is ready for use. The other end of the needle is firmlyanchored in a cylindrical hub 38 slidable within the aforesaid tracks33-33 from the position seen in FIGURES 7 and 8 with the needle hubabuting the end portion of the tube 31 to the position seen in FIGURE 9with the needle hub abutting the opposite end portion of the tube 31.

A catheter 39 has the outer end thereof firmly anchored in a plug 40 inthe outer end of the tube 31 so that communication through the nipple 35is with the catheter only. The catheter extends through the tube 31 intothe lumen of the needle 36 and terminates just inside the needle point37. That portion of the catheter between the tracks 33-33 is notshielded, such not being necessary since only the part of the catheterwithin the lumen of the needle enters the patents body.

The device of FIGURES 7, 8 and 9 may be used in similar manner to thosepreviously described. In this instance, the placement unit may beremoved from its sterile wrappings, connected to an infusion system, thecatheter flushed out if desired, infusion stopped, and the hub 38 of theneedle grasped between the thumb and finger of the attending surgeon.Venipuncture is then made to the desired extent, and it is a simpleexpedient to hold the tube 31 in position and retract the needle bysliding the hub 38 from the position seen in FIGURE 8 to the positionseen in FIGURE 9, thus retracting the needle from the placed catheter.When the needle is fully retracted, the hub passes by a pair of detents41-41 in the tracks 33-33, and the resiliency of the tracks p rm ts thehub to pass between the detents which then fall into position back tothe retracted hub and effectively lock it in that position against anyadvance movement relatively to the catheter. As seen in FIGURE 9, whenthe needle is fully retracted, the point 37 of the needle will be insidethe nipple 34. And the patient is fully protected from the needle. Thedevice may be adhesively attached to the body of the patient in themanner above described.

It will be understood that modification and variations may be effectedwithout departing from the scope of the novel concepts of the presentinvention.

We claim as our invention:

1. In combination in a catheter placement unit, including tubular means,

a hollow needle having a pointed end slidable in said means andinitially disposed with the pointed end projecting out one end thereof,

retracting means on the other end of the needle for retracting saidneedle back within said tubular means, [on the other end of saidneedle,]

a catheter extending through said tubular means with one end terminatingjust inside the pointed end of the needle,

means [fixedly securing the other end of the catheter to the tubularmeans and] for connecting the other end of said catheter to an infusionsystem in a leakproof manner, said connecting means being such that theneedle can be retracted without retracting the catheter,

said tubular means [being in the form of] including a plastic conduithaving an opening in the side wall thereof, and

a part of said retracting means extending through said opening so thatupon manipulation of said retracting means, said needle is retractedback within said tubular means thereby exposing said catheter.

2. A [In a] catheter placement unit as in claim 1 wherein saidretracting means comprises a lanyard, a needle and a catheter assemblyin which the needle and catheter are telescopically associated adjacentone end of the catheter, said catheter being in a sterile sheath, andmeans on the other end of the catheter for connection to an infusionsystem, wherein the improvement comprises said needle being slidablymounted in said sheath,

a lanyard disposed in said sheath and connected to said needle toretract the same relatively to said catheter after entry of saidcatheter into a body lumen,

the catheter being secured to said tubular means to connect the same toan infusion system and cannot be moved relatively to said needle] 3. Incombination in a catheter placement unit, including tubular means,

a hollow needle having a pointed end and being slidable in said meansand initially disposed with the pointed end projecting out one endthereof,

retracting means on the other end of said needle, for retracting saidneedle back Within said tubular means, [on the other end of saidneedle,]

a catheter [secured to and] extending through said tubular means withone end terminating just inside the pointed end of the needle,

means to connect the other end of the catheter to an infusion system ina leakproof manner, said connecting means being such that the needle canbe retracted without retracting the catheter,

a flexible holder joined to the end of said tubular means from which theneedle projects,

means defining a groove in said holder in which said retracting meansare initially disposed, and

opposed wings on said holder which when bent upwardly and grippedtogether tighten said groove defining means on said retracting means tohold the needle firmly while a body puncture is made.

4. The combination of claim 3, including means to limit the retractivemovement of the needle relatively to the catheter to a position whereinthe pointed end of said needle rests in the groove of the holder.

5. In combination in a catheter placement unit, includtubular means,

a hollow needle having a pointed end slidable in said means andinitially disposed with the pointed end projecting out one end thereof,

retracting means on the other end of said needle, for retracting saidneedle back within said tubular means [on the other end of said needle,]

a catheter extending through said tubular means with one end terminatingjust inside the pointed end of the needle,

means to connect the other end of the catheter to an infusion system ina leakproof manner, said connecting means being such that the needle canbe retracted without retracting the catheter,

locking means carried by said tubular means to hold said needle inretracted position after placement of the catheter in a body lumenagainst advance movement relatively to the catheter,

said retracting means comprising a grippable hub on said needle,

a pair of opposed tracks defined by said tubular means between whichsaid needle is slidable, and said locking means comprising an inwardlyprojecting detent on at least one of said tracks. [J

[said tracks being sufiiciently flexible for said hub to pass by saiddetent and lock therebehind] 6. The combination of claim 5, including ahollow nipple on said tubular means having a bore of a size to justaccommodate the needle and which extends well beyond the point of saidneedle when the needle is retracted to maintain the catheter inalignment with the lumen of the needle.

7. In a catheter placement unit having a needle and catheter assembly inwhich the needle and catheter are telescopically associated adjacent oneend of the catheter, and means on the other end of the catheter forconnection to an infusion system, said connecting means being such thatthe needle can be retracted without retracting the catheter, wherein theimprovement comprises a flexible holder having a groove therein in whichthe needle end of said essembly is positioned,

opposed wings on said holder which when bent upwardly and grippedtogether tighten the walls of said grove on said assembly to hold thesame firmly while the needle and catheter are entered into a body lumen,and

retracting means attached to said needle to retract the same relativelyto the catheter when said wings are released after body entry.

8. A combination as in claim I, wherein the means for connecting theother end of the tubular means to an infusion system fixedly secures theother end of the catheter to the tubular means.

9. A combination as in claim 3, wherein the catheter is secured to thetubular means.

10. A combination as in claim 5, wherein the tracks are sujficientlyflexible for the hub to pass by the detent and lock therebehind.

II. In combination in a catheter placement unit:

a tubular means,

a hollow needle having a pointed end and being slidable in the tubularmeans and initially disposed with the pointed end projecting out one endthereof,

l grippable means fixedly secured to said needle for retracting saidpointed end of the needle into the tubular means,

a catheter extending through the tubular means with one end therofwithin the needle,

means to connect the opposite end of said catheter to an infusion systemin a leakproof manner, said connecting means being such that the needlecan be rectracted without retracting the catheter,

said tubular means including a conduit having an opening in the sidewall thereof, and

a part of said retracting means extending through said opening, so that,upon manipulation of said retracting means, said needle is retractedwithin said tubular means thereby exposing said catheter.

12. A combination as in claim I], wherein there is additionally providedlocking means carried by the tubular means to hold the needle inretracted position against advance movement relative to the tubularmeans after placement of the catheter in a body lumen.

13. In combination in a catheter placement unit:

tubular means,

a hollow needle having a pointed end and being slidable in the tubularmeans and initially disposed with the pointed end projecting out one endthereof,

flexible holding means encompassing the needle for manual gripping andtightening around the needle so said needle can be pushed to accomplisha venipunctttre without retracting into the tubular means,

References Cited The following references, cited by the Examiner, are ofrecord in the patented file of this patent or the original patent.

UNITED STATES PATENTS 2,057,726 10/1936 Landis 128-214 R 2,937,6435/1960 Elliot 128-214.4 3,055,361 9/1962 Ballard 128214.4 3,064,64811/1962 Bujan 128-214 R 3,262,449 7/1966 Pannier et a1. 128214.43,324,853 6/1967 CZOrny et al. 128-214.4

DALTON L. 'PRULUCK, Primary Examiner US. Cl. X.R. 128--221

